1. Field of the Invention
The present invention relates to calibration of radiation devices, and more particularly to the automated specification testing, checking and calibration of radiation therapy devices for use in the oncology field.
2. Description of the Related Art
System calibration methods presently in use for specification testing, checking and calibration of radiation devices are cumbersome and error prone. In such known systems, measurement data is typically recorded by hand and is reviewed several times to verify the accuracy and completeness of the data. Scan data collection is accomplished through manual control of the radiation therapy devices using scanning equipment which requires each scan to be manually initiated.
The radiation therapy device settings are manually keyed into the scanning equipment software, and verification of the data entry is accomplished through a review of the scan printouts. Finally, the results of the analysis of the scan are manually recorded. The scenario outlined above applies to most clinical setting. Similar tasks are performed on a routine basis to verify proper operation of the radiation therapy devices.
A system calibration department of a medical device manufacturer is typically responsible for verifying that the radiation therapy device interlocks are operational and calibrated according to various machine parameters to ensure that the therapy device meets all performance specifications. The work performed by the system calibration department is documented in the DHR. The section of the DHR completed currently includes several pages that are filled out by hand. This procedure used may be broken into two main sections, pre-test and the radiation test.
The various machine interlocks are tested as part of the pre-test section. Typically a fault condition is simulated and the test technician verifies that an interlock trips. The fault condition is then removed and the test technician verifies that the interlock clears. The test technician then records his initials and the date in the appropriate section of the DHR.
The radiation test consists of testing to ensure that the machine meets its performance specifications. Several components of the radiation therapy devices need to be aligned as part of this procedure. These include the bending magnet, defining head jaws, flattening filters, and the light field. Typically rough scans are performed and adjustments are made to correct any alignment errors. Once the alignment is correct, a series of final scans are made and recorded as part of the DHR to document the machine performance. There are also several machine parameters that are calibrated as part of this procedure. These parameters affect the stability and intensity of the beam. They are calibrated using external equipment, such as oscilloscopes, multi-meters, and the scanning equipment. Once the alignment and calibration is complete, any remaining performance specifications are tested to ensure that the machine is operating properly. These include specifications such as rotational treatments and leakage measurements. Machine configuration information, machine parameters, and test equipment used are recorded as part of the DHR.
To this end, it would be desirable to provide a system for automatically collecting all information required for the device history records, which allows the information to be stored in a database. It would be further desirable to eliminate the human user interface in a calibration and testing system while performing a number of tests on the radiation devices. Accordingly, after the radiation device being tested is turned on by the user, the system may then perform the necessary programming via a communications network to carry out a series of tests and calibration checks. Accordingly, the package should allow the technicians to quickly and accurately record all data required for machine calibration, and allow information to be available on the company intranet or the like for access from remote locations.